VALGENT-3 检测试剂盒 HPV 风险检测的临床性能评估
Evaluation of the Clinical Performance of the HPV-Risk Assay Using the VALGENT-3 Panel.
机构信息
Department of Pathology, Cancer Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
出版信息
J Clin Microbiol. 2017 Dec;55(12):3544-3551. doi: 10.1128/JCM.01282-17. Epub 2017 Oct 11.
Human papillomavirus (HPV) testing is increasingly being incorporated into cervical cancer screening. The Validation of HPV Genotyping Tests (VALGENT) is a framework designed to evaluate the clinical performance of various HPV tests relative to that of the validated and accepted comparator test in a formalized and uniform manner. The aim of this study was to evaluate the clinical performance of the HPV-Risk assay with samples from the VALGENT-3 panel and to compare its performance to that of the clinically validated Hybrid Capture 2 assay (HC2). The VALGENT-3 panel comprises 1,300 consecutive samples from women participating in routine cervical cancer screening and is enriched with 300 samples from women with abnormal cytology. DNA was extracted from original ThinPrep PreservCyt medium aliquots, and HPV testing was performed using the HPV-Risk assay by investigators blind to the clinical data. HPV prevalence was analyzed, and the clinical performance of the HPV-Risk assay for the detection of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) and CIN2 or worse (CIN2+) relative to the performance of HC2 was assessed. The sensitivity of the HPV-Risk assay for the detection of CIN3+ was similar to that of HC2 (relative sensitivity, 1.00; 95% confidence interval [CI], 0.95 to 1.05; = 1.000), but the specificity of the HPV-Risk assay was significantly higher than that of HC2 (relative specificity, 1.02; 95% CI, 1.01 to 1.04; < 0.001). For the detection of CIN2+, similar results were obtained, with the relative sensitivity being 0.98 (95% CI, 0.93 to 1.02; = 0.257) and the relative specificity being 1.02 (95% CI, 1.01 to 1.03; < 0.001). The performance of the HPV-Risk assay for the detection of CIN3+ and CIN2+ was noninferior to that of HC2, with all values being ≤0.006. In conclusion, the HPV-Risk assay demonstrated noninferiority to the clinically validated HC2 by the use of samples from the VALGENT-3 panel for test validation and comparison.
人乳头瘤病毒（HPV）检测越来越多地被纳入宫颈癌筛查。验证 HPV 基因分型检测（VALGENT）是一个旨在以规范化和统一的方式评估各种 HPV 检测相对于经验证和接受的比较检测的临床性能的框架。本研究的目的是评估 HPV-Risk 检测在 VALGENT-3 面板样本中的临床性能，并将其性能与临床验证的杂交捕获 2 检测（HC2）进行比较。VALGENT-3 面板包含 1300 名参加常规宫颈癌筛查的女性连续样本，并富集了 300 名细胞学异常女性的样本。从原始的 ThinPrep PreservCyt 介质等分试样中提取 DNA，并由对临床数据盲法的研究人员使用 HPV-Risk 检测进行 HPV 检测。分析 HPV 流行率，并评估 HPV-Risk 检测在检测宫颈上皮内瘤变 3 级或更高级别（CIN3+）和 CIN2 或更高级别（CIN2+）方面相对于 HC2 的性能。HPV-Risk 检测检测 CIN3+的敏感性与 HC2 相似（相对敏感性，1.00；95%置信区间[CI]，0.95 至 1.05； = 1.000），但 HPV-Risk 检测的特异性明显高于 HC2（相对特异性，1.02；95%CI，1.01 至 1.04； < 0.001）。对于检测 CIN2+，也得到了类似的结果，相对敏感性为 0.98（95%CI，0.93 至 1.02； = 0.257），相对特异性为 1.02（95%CI，1.01 至 1.03； < 0.001）。HPV-Risk 检测在检测 CIN3+和 CIN2+方面的性能不劣于 HC2，所有 值均≤0.006。总之，HPV-Risk 检测在 VALGENT-3 面板样本中进行验证和比较时，使用样本显示出对临床验证的 HC2 的非劣效性。
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